Ultrasound Guided Sandostatin LAR Injection in Acromegaly

Condition(s) targeted: Acromegaly

Intervention: Sandostatin LAR (Drug); Sandostatin LAR (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Cedars-Sinai Medical Center

Official(s) and/or principal investigator(s):
John D Carmichael, MD, Principal Investigator, Affiliation: Cedars-Sinai Medical Center

Overall contact:
Billy Gellepis, Phone: (310) 423-3395, Email: gellepisw@cshs.org

The purpose of this study is to determine the difference in drug levels of Sandostatin after IM injection of Sandostatin LAR without ultrasound guidance (as is the standard of care) compared to drug levels of Sandostatin after IM injection of Sandostatin LAR with ultrasound guidance in subjects with Acromegaly.

Official title: Does Ultrasound-Guidance Improve the Delivery and Efficacy of Intramuscular (IM) Injection of Sandostatin LAR in the Treatment of Acromegaly

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Serum drug levels of octreotide after third month of ultrasound guided IM injection of octreotide LAR compared to third month of non-ultrasound guided IM injection of octreotide LAR

Secondary outcome: IGF-I levels after ultrasound guided octreotide LAR injection compared to non-ultrasound guided injections

Detailed description: IM intragluteal injections have been reported to be inaccurate in their placement in the intramuscular compartment when performed as dictated by the current standard of care. This inaccuracy of placement may have an effect on the efficacy of drugs delivered by the IM route. Furthermore, the inaccuracy of IM injections was found to be directly related to BMI and was found to be more inaccurate in female subjects. Ultrasound guidance of IM injections will improve the accuracy of placement of IM injections and may improve drug levels and efficacy of Sandostatin LAR in the treatment of Acromegaly.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male and female patients ≥18 years old

- Patients with active acromegaly due to a pituitary adenoma. Historical data

indicating a diagnosis of acromegaly based on circulating IGF-I concentration elevated compared to age and gender matched controls OR GH >1 mcg/l at 120 Minutes of a two hour OGTT.

- Currently being treated with Sandostatin LAR and have been treated with a stable dose

for 3 months prior to entry into the study.

- Patients with diabetes may be included, blood glucose and diabetic treatments are to

be monitored closely during the trial in these subjects

- Patients have provided written informed consent

Exclusion Criteria:

- Uncontrolled diabetes mellitus

- Patients who are pregnant or lactating

- Patients who have a known hypersensitivity to Sandostatin acetate or other related

drug or compound

- Patients with current gallstones

- Patients with a past or current history of cancer, except for basal cell carcinoma or

in situ cancer of the cervix

- Patients with a history of hepatic disease (patients with minimal, i. e., <3Xs the

upper limit of normal for LFTs indicative of hepatic steatosis, MAY participate)

- Patients who have received glucocorticoid therapy within the past 6 months, or who

are currently receiving any chemotherapeutic agents, or exogenous growth hormone therapy

- Patients who have received other investigational drugs administered or received

within 30 days of study entry

- Patients with unacceptable concomitant diagnoses, or who have received medications

and/or therapies (i. e., any concomitant illnesses or therapies that would place the patient at increased risk, or would, in the opinion of the investigator or sponsor, interfere with the evaluation of efficacy or safety) Interruption or discontinuation of treatment

Billy Gellepis, Phone: (310) 423-3395, Email: gellepisw@cshs.org

Cedars-Sinai Medical Center, Los Angeles, California 90048, United States; Recruiting
John D Carmichael, MD, Principal Investigator
Shlomo Melmed, MD, Sub-Investigator
Vivien Bonert, MD, Sub-Investigator

Starting date: July 2007
Last updated: August 18, 2010